Piramal Pharma Solutions, a provider of sterile drug product development and manufacturing services, has announced plans for a $25 million expansion of its facilities in Lexington (Kentucky, USA).

Piramal Pharma Solutions’ plan focuses on expanding the Lexington site capabilities and capacity for commercial aseptic manufacturing. This will be done by increasing vial filling capability and lyophilization capacity, as well as upgrades to the associated facilities and utilities.

Piramal’s Lexington site has a strong pipeline of products, which are expected to be commercialized in next 3–5 years. Add to that the fast growing sterile market in the US, recent consolidations in the CMO space and shutdown of many manufacturing sites in the US, has created a big demand for quality manufacturers in the sterile segment.

The sterile market in the US and Europe is growing at a healthy rate of 11% and the contract manufacturing in the sterile dosage form is growing at 13% year on year. Piramal believes that it can take advantage of the market situation and grow it Lexington business multifold.

Phase I of the expansion of the Lexington facility will add a new manufacturing suite including a high speed vial filling machine that provides controlled/safe environment for handling potent materials with an advantage of automated vial washing and sterilization. Also as part of the first phase of expansion, Piramal will install a new isolator based vial filler in its existing manufacturing suite, which is a newer technology and considered much higher in quality standards.

Combined, the two fillers installed under Phase I of the expansion will increase the company’s vial filling capabilities by more than 5-fold. Phase II of the expansion will include the installation of two state-of-the-art lyophilizers and are planned to integrate with the new filler line in the new manufacturing suite offering dedicated capacity for both potent and non-potent products

Vivek Sharma, CEO, Pharma Solutions, Piramal Enterprises, commented: “Since our initial investment, the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this next phase of investment to enhance capability and capacity. We appreciate the active support from the State of Kentucky, the local Government, and most importantly, the community, as we continue our growth plans in Lexington. The expansion in our capacity at Kentucky will help us better serve our customers who are looking for us to deliver solutions that will improve the standard of care.”

Bill Wedlake, President of Piramal Pharma Solutions Formulations Business, added: “We are extremely excited to initiate this expansion and continue the company’s vision of becoming the premier aseptic manufacturing service provider that began with the acquisition of Coldstream Laboratories in January of 2015.”